(188 days)
The TattooStar R is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.
Some examples of pigment lesions are:
Lentigines, Café-au-lait-blotches, Ephalides, BenignNaevi such as Naevus of Ota, Naevus of Ito, Epidermal Naevi, Congenital Naevi, Beckers Naevi, Blue Nevus, Naevus Spillus and Mongolian Spot.
The TattooStar R is a q-switched solid state lasers emitting wavelengths of 694 nm (Rubylaser). It consists a laser enclosure and optic delivery system (articulated mirror arm).
This 510(k) premarket notification for the TattooStar R device indicates that no nonclinical or clinical performance data was provided or required to demonstrate substantial equivalence.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance criteria and reported device performance: No criteria were outlined, and no performance data was presented.
- Sample size and data provenance for the test set: No test set was used.
- Number of experts and their qualifications: No experts were involved in establishing ground truth for a test set.
- Adjudication method: Not applicable as there was no test set or expert review.
- MRMC comparative effectiveness study: Not conducted.
- Standalone performance study: Not conducted.
- Type of ground truth used: Not applicable as no ground truth was established for performance evaluation.
- Sample size for the training set: Not applicable as the device's performance was not evaluated through a training set.
- How ground truth for the training set was established: Not applicable.
The FDA's decision to clear the device was based on its substantial equivalence to a previously legally marketed predicate device, the RubyStar. This means the FDA determined that the TattooStar R has the same intended use, similar technological characteristics (same principle of operation, same wavelength), and raises no new questions of safety or effectiveness compared to the RubyStar, even though the RubyStar has a long-pulsed mode not present in the TattooStar R.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.